With Toxicology Databases, FDA & Industry Aim To Use, Not Lose, Safety Data
Executive Summary
Both FDA and industry are organizing databases to make the toxicities of known compounds available to the researchers making decisions in early development. Those efforts at computational toxicology are being met with a great deal of excitement
You may also be interested in...
Pre-Market Safety Must Balance Statistics With Clinical Discernment – FDA
The next chapter for drug safety will be to more accurately quantify harm and risk in the pre-market setting, FDA's Office of Biostatistics Director Robert O'Neill said at a recent drug safety conference
Pre-Market Safety Must Balance Statistics With Clinical Discernment – FDA
The next chapter for drug safety will be to more accurately quantify harm and risk in the pre-market setting, FDA's Office of Biostatistics Director Robert O'Neill said at a recent drug safety conference
Nephrotoxicity Biomarker Prepares For Clinic After FDA Blesses Animal Test
The firms that obtained FDA/EMEA qualification of seven nephrotoxicity biomarkers for preclinical drug testing are midway through development of a protocol to test their efficacy in a clinical trial